Spironolactone
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- SPIRONOLACTONE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- CLINICAL STUDIES
- INDICATIONS & USAGE
- SPIRONOLACTONE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- SPIRONOLACTONE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
SPIRONOLACTONE DESCRIPTION
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
CLINICAL STUDIES
INDICATIONS & USAGE
Primary Hyperaldosteronism for:
Edematous Conditions For Patients With:
Essential Hypertension
Hypokalemia
Severe heart failure (NYHA class IIIIV)
PRECAUTIONS: Pregnancy
There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
SPIRONOLACTONE CONTRAINDICATIONS
WARNINGS
PRECAUTIONS: General
CLINICAL STUDIES, Severe heart failureDOSAGE AND ADMINISTRATION, Severe heart failure
PRECAUTIONS: Drug Interactions
PRECAUTIONS
GeneralINFORMATION FOR PATIENTS
LABORATORY TESTS
DRUG INTERACTIONS
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic EffectsNURSING MOTHERS
PEDIATRIC USE
SPIRONOLACTONE ADVERSE REACTIONS
PRECAUTIONS
WARNINGSPRECAUTIONS
OVERDOSAGE
DOSAGE & ADMINISTRATION
WARNINGS: Hyperkalemia in patients with severe heart failure
HOW SUPPLIED
INACTIVE INGREDIENT
calcuim sulfatecorn starch
crospovidone
dextrose
hypromellose
magnesium stearate
maltodextrin
natural peppermint flavor
polydextrose
polyethylene glycol
povidone
silicon dioxide
titanium dioxide
triacetin
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
SpironolactoneSpironolactone TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
